Verizon mHealth Solution for Patients With Peripheral Artery Disease (PAD)

Status Completed

Clinical Trial Summary

The purpose of this study is to understand the effects that a three month lifestyle-based mobile health (mHealth) peripheral artery disease (PAD) prevention program will have on improving physical activity, fitness, important PAD risk factors and quality of life (QOL) in patients with PAD.

By testing a novel mHealth intervention focused on lifestyle modification, this trial will address a critical evidence gap in the care of PAD patients. PAD patients are not eligible for cardiac rehabilitation and therefore struggle with unhealthy lifestyles, and these patients currently have no lifestyle-based care strategies to help them. The results of this study have the potential to lead to new sustainable and resource-efficient, lifestyle-based preventive care strategies for patients with stable PAD.

Clinical Trial Description

This is a single-center, randomized trial designed to examine the hypothesis that a lifestyle-based mHealth peripheral artery disease (PAD) prevention program will improve physical activity, fitness, important PAD risk factors and quality of life (QOL).

The investigators may enroll up to 55 men and women being evaluated for leg pain from Duke PAD cardiovascular clinics or after lower extremity angioplasty in the Duke catheterization laboratory. Of the 55 men and women volunteers who may be initially consented, the investigators anticipate a portion (potentially 20%) may drop out during the study timeline, and approximately 45 are expected to complete this study. Following informed consent and baseline testing, the participants will be randomized (1.25:1.00) into either a mHealth (N=25) or usual care group (N=20) [for comparison] for a 12-week period. All patients will be evaluated for walking ability on a treadmill test, quality of life questionnaires, health literacy related to PAD and the most important risk factors specific to PAD (blood glucose if diabetic, daily physical activity and blood pressure). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02472561
Study type	Interventional
Source	Duke University
Contact
Status	Completed
Phase	N/A
Start date	July 2015
Completion date	November 7, 2017

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